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Trial record 24 of 242 for:    furosemide

Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study (SUBQ-HF)

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ClinicalTrials.gov Identifier: NCT03170219
Recruitment Status : Terminated (Slow enrollment)
First Posted : May 30, 2017
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Adrian Hernandez, Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Heart Failure
Decompensated Heart Failure
Intervention Combination Product: subcutaneous furosemide and sc2wear device
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Period Title: Overall Study
Started 7 4
Completed 7 4
Not Completed 0 0
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care Total
Hide Arm/Group Description

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines. Total of all reporting groups
Overall Number of Baseline Participants 7 4 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 4 participants 11 participants
61  (15.2) 64.3  (6.4) 62.2  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 4 participants 11 participants
Female
5
  71.4%
4
 100.0%
9
  81.8%
Male
2
  28.6%
0
   0.0%
2
  18.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 4 participants 11 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
7
 100.0%
4
 100.0%
11
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 4 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  85.7%
3
  75.0%
9
  81.8%
White
1
  14.3%
1
  25.0%
2
  18.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 4 participants 11 participants
7 4 11
1.Primary Outcome
Title Patient Safety Measured by Serious Adverse Events
Hide Description measured by serious adverse events
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description:

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Overall Number of Participants Analyzed 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Composite Safety Endpoint of Death, Sustained Ventricular Arrhythmias, and Severe Hypokalemia
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description:

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Medical Costs From Randomization Through 30 Days
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description:

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Days Alive and Outside the Hospital Through 14 Days
Hide Description [Not Specified]
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description:

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title 30 Day Heart Failure Readmission
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description:

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title 30 Day ED Visit for Heart Failure
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description:

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Death at 30 Days
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description:

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Overall Number of Participants Analyzed 7 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Change in Breathlessness Through Day 7
Hide Description On a 0-10 scale of breathlessness
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description:

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change in Renal Function Using eGFR Baseline to 30 Days
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description:

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change in NT Pro BNP From Baseline to 30 Days
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description:

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Time of consent to day 30
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subcutaneous Furosemide and sc2wear Device Usual Care
Hide Arm/Group Description

Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.

subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care

Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
All-Cause Mortality
Subcutaneous Furosemide and sc2wear Device Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Subcutaneous Furosemide and sc2wear Device Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subcutaneous Furosemide and sc2wear Device Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/7 (42.86%)      1/4 (25.00%)    
Injury, poisoning and procedural complications     
Ligament Sprain  1  1/7 (14.29%)  2 0/4 (0.00%)  0
Fall  1  0/7 (0.00%)  0 1/4 (25.00%)  1
Investigations     
Transferrin Saturation Decreased  1  1/7 (14.29%)  1 0/4 (0.00%)  0
Metabolism and nutrition disorders     
Hyponatraemia  1  1/7 (14.29%)  1 0/4 (0.00%)  0
1
Term from vocabulary, Medra
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rachel Olson, Project Leader
Organization: Duke Clinical Research Institute
Phone: 919-668-5590
EMail: rachel.e.olson@duke.edu
Layout table for additonal information
Responsible Party: Adrian Hernandez, Duke University
ClinicalTrials.gov Identifier: NCT03170219     History of Changes
Other Study ID Numbers: Pro00070619
First Submitted: May 6, 2017
First Posted: May 30, 2017
Results First Submitted: November 29, 2018
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019